Ecacy and safety of clinically managed weight loss programs: A systematic review and meta-analysis protocol
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Efficacy and safety of clinically managed weight
loss programs: A systematic review and meta-
analysis protocol
Katrina Cachero ( kp_cachero@hotmail.com )
University of Manitoba https://orcid.org/0000-0002-9770-5458
Matthew Granger
University of Manitoba
Rebecca C. Mollard
University of Manitoba
Nicole Askin
University of Manitoba
George N. Okoli
University of Manitoba
Ahmed M. Abou-Setta
University of Manitoba
Dylan MacKay
University of Manitoba
Research Article
Keywords: obesity, weight loss program, dietitian, exercise, psychology, physician, nurse practitioner
Posted Date: June 10th, 2021
DOI: https://doi.org/10.21203/rs.3.rs-242769/v1
License: This work is licensed under a Creative Commons Attribution 4.0 International License.
Read Full License
Page 1/7Abstract
Background: Obesity has become a major driver in the burden of chronic diseases. The Canadian Clinical
Practice Guidelines recommends a lifestyle intervention for the management and prevention of obesity.
This includes behaviour modification, dietary counselling, and physical activity. With the market
overwhelmed with weight loss programs, majority are focused on low-calorie diets and general
recommendations for exercise. Most are not personalized and are not administered by health care
professionals. An interdisciplinary team of highly trained health care professionals have the ability to
provide medically sound and safe advice in all aspects of an individuals’ life, such as, lifestyle, sleep,
mental health, and behaviours. A clinically-managed weight loss program is defined as a team including
a dietitian, and/or exercise professional, and/or psychologist, and/or physician or nurse practitioner
oversight. With limiting results in the literature regarding clinically-managed weight loss programs, it is
difficult to conclude whether it may be effective. Therefore, the objective of this systematic review is to
assess clinically-managed weight loss programs, with physician or nurse practitioner oversight in
comparison to non-clinically-managed weight loss programs with no physician oversight or nurse
practitioner oversight in adults who are living with overweight or obesity.
Methods: A literature search will be executed by a knowledge synthesis librarian on MEDLINE, Cochrane
Central, Embase, PsycINFO, and CINAHL. The data collected will be extracted, stored, and managed in MS
Excel 2016. The extraction of the data will include study details, study population details, health team
details, intervention details, and outcome details.
Discussion: The prevalence of obesity has been increasing throughout the decades. Results from this
systematic review may aid in recommending a more clinically safe weight loss program for those who
struggle with overweight or obesity.
PROSPERO ID: CRD42020170014
Background
The prevalence of adults who are overweight or with obesity have been increasing throughout the past
three decades with almost two-thirds of Canadian adults being overweight or with obesity (1)(2). This
increasing prevalence is believed to be a major driver in the burden of chronic diseases (3). The World
Health Organization defines overweight and obesity as abnormal or excessive fat accumulation that may
impair health (4). There are different ways to measure overweight or obesity with the most common
measurement being Body Mass Index (BMI). Individuals with a BMI over 25 are classified as overweight
and those over 30 are classified with obesity. The current Canadian Clinical Practice Guidelines (CCPG)
on the management and prevention of obesity in adults recommends a comprehensive lifestyle
intervention including behavior modification, dietary counselling and physical activity as the first line
treatment option to achieve clinically significant weight loss (5). Weight reduction is well documented to
Page 2/7improve cardiovascular risk factors (such as blood pressure, low-density lipoprotein-cholesterol, and
triglycerides) and blood glucose metabolism in individuals who are overweight or with obesity (5)(6).
Weight loss programs are primarily focused on low-calorie diets and rarely includes medical oversight.
Weight loss programs such as, Weight Watchers, Jenny Craig, or Nutrisystems have a nutrition, physical
activity, and behavioural strategies component but are not personalized to the individual or administered
by health care professionals (7). Based on the 2006 CCPG, a weight management program should
involve a nutrition health professional, an exercise professional, and a clinical psychologist (5). With this
type of interdisciplinary team, all aspects of an individuals’ life are considered (i.e. lifestyle, sleep, mental
health, behaviours). A weight loss program which is directed by dietitians, and/or exercise professional,
and/or psychologist, with physician or nurse practitioner (prescriber) oversight, is considered a clinically
managed weight loss program. Clinicians are able to actively monitor a participants’ health and
potentially adjust medications throughout the weight loss program. A study by Tapsell et al. (8) found
that an interdisciplinary intervention with physician oversight produced greater and more clinically
significant weight loss. Additionally, interdisciplinary weight loss programs have shown improvement in
other areas other than weight, such as, eating behaviours, lipid profiles, aerobic capacity, and overall
quality of life (8-10).
The consumer marketplace is overwhelmed with weight loss programs; with the majority being focused
on calorie-reduced diets (7). Not all of these programs include exercise, most do not include physician
oversight, and may not be customizable. Clinician oversight, may provide additional benefit because
clinicians are highly trained professionals and have ability to prescribe or adjust medications, and provide
medically sound and safe advice. However, some potential drawbacks of physician oversight to a weight
loss program’s success may include the added expense, participant stress or feelings of judgement, and
with the increased number of health care professional involvement, there may be hierarchy conflict.
With varying results in the literature, it is difficult to conclude whether clinician oversight in weight loss
programs is more effective or not. Therefore, the objective of this systematic review is to assess the
efficacy of clinically-managed weight loss programs, with physician or nurse practitioner oversight, in
comparison to non-clinically-managed weight loss programs with no physician or nurse practitioner
oversight in adults who are overweight or with obesity.
Research Question
Do weight loss programs in adults who are overweight or with obesity directed by dietitians, and/or
exercise professionals, and/or psychologists, with physician or nurse practitioner oversight, lead to
greater program success compared to similar programs without physicians or nurse practitioners?
Methods
Study selection
Page 3/7A literature search strategy for MEDLINE will be designed by a knowledge synthesis librarian and peer
reviewed by a second, independent librarian using the PRESS checklist (11). The peer-reviewed search
strategy will then be adapted for other bibliographic databases (Cochrane Central, Embase, PsycINFO and
CINAHL) and executed by a knowledge synthesis librarian. Identified citations from the executed searches
will be screened for eligibility by two independent systematic reviewers on Rayyan (Rayyan, Doha, Qatar)
(12). The number of ineligible citations at the title/abstract screening stage will be recorded, and both the
number and reason for ineligibility will be recorded at the full-text article screening stage. Any
disagreements during these screening stages will be resolved by discussion between the two systematic
reviewers with a third reviewer to adjudicate, if necessary.
Eligibility criteria
The following studies will be included:
1. Population: overweight or with obesity (BMI >25) adults (18 – 65 years of age) from North America,
Europe, Australia, and New Zealand (>80% of trial population)
2. Intervention: clinically-managed weight loss programs with physician or nurse practitioner oversight
3. Comparator: weight loss programs with no physician or nurse practitioner oversight
4. Outcomes:
Primary; weight
Secondary: BMI, waist circumference, body fat percentage, lipid profile, blood pressure, adherence to
program, withdrawal from program, quality of life,
Safety: any reported adverse events
5. Study design: randomized controlled trials (parallel or cluster-design). For cross-over trials, we will use
the data before the cross-over.
6. Publications from the year 1990 to date of search
7. Full-text manuscript in English language (for feasibility)
The cost of living, access to food options and healthcare systems around the world differ markedly,
countries with characteristics similar to the Canadian setting were selected, this includes North America,
Europe, Australia, and New Zealand.
Data extraction
We will utilize data extraction forms developed in MS Excel 2016 (Microsoft Corporation, Redmond, WA,
USA)(13) and piloted on a small selection of studies for quality assurance. Extracted data will be stored
and managed in MS Excel. Two systematic reviewers will independently extract data from included
Page 4/7studies. Any disagreements will be resolved by discussion between the two reviewers, and a third reviewer
will adjudicate if necessary. The following data will be extracted from included studies:
Study details:
name of first author, year study was conducted, year of publication, country, setting, population
demography, study size, and funding source
Study population details: type of population (for example, adults), age, sex distribution, health and
socioeconomic status
Health team details: profession
Intervention details: name, type, method of intervention, measure (amount/extent), duration, contact
hours
Outcome details: (See above) Data will be extracted at the end of the trial and at the longest reported
follow-up.
Assessment of risk of bias
We will assess risk of bias using the Cochrane Risk of Bias Tool 2.0 (14). This tool assigns a judgment of
high, some concerns, and low risk of bias for each of the following domains: bias arising from the
randomization process, bias due to deviations from intended interventions, bias due to missing outcome
data, bias in measurement of the outcome, and bias in selection of the reported result. Any
disagreements will be resolved by discussion between the two reviewers or by involving a third reviewer if
necessary.
Data analysis
We will conduct meta-analysis where feasible, using a random effects model implemented in RevMan
(Version 5.3.5) (15). We will express pooled continuous data as mean differences or as standardized
mean differences where measures of the same outcome are with different scales, presenting the 95%
confidence intervals. Pooled dichotomous data will be presented as a risk ratio, or for rare outcomes
using the Peto-Odds Ratio. We will assess and quantify statistical heterogeneity between included studies
using the I-squared statistic (I2). We will assess for publication bias visually using funnel plots of effect
size versus sample size for each included study and using Egger’s regression test.
Then following a priori subgroup and sensitivity analyses are proposed depending on the number of
studies included and the availability of data: differences between low risk of bias and some
concerns/high risk of bias studies, intervention types, clinician type, population type, participant sex,
comorbidity status, and geographical location (for example, continent).
Study Outcome Dissemination
Page 5/7In addition to a peer-reviewed academic publication, we will present our findings at appropriate academic
meetings.
Abbreviations
BMI: Body Mass Index
CCPG: Canadian Clinical Practice Guidelines
CDIC: Chronic Disease Innovation Centre
WI: Wellness Institute
SOGH: Seven Oaks General Hospital
Declarations
Ethics Approval and Consent to Participate
Not applicable.
Consent for Publication
Not applicable.
Availability of Data and Materials
No datasets have been generated related to this published article.
Competing Interests
One of the authors is funded from a Mitacs Accelerate Fellowship. Mitacs is partnered with the Chronic
Disease Innovation Centre (CDIC); which is a not for profit Canadian corporation. Both CDIC and Wellness
Institute (WI) are located within Seven Oaks General Hospital (SOGH), the WI offers clinically managed
weight loss programs with physician oversight.
Funding
This systematic review is funded by the Mitacs Accelerate Fellowship partnered with CDIC, which is the
research arm of the WI and SOGH.
Authors’ Contributions
Each author made substantial contributions to the creation of this paper. All authors have read and
approved the final manuscript.
Page 6/7Acknowledgments
Not applicable.
References
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Supplementary Files
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MEDLINEPreliminarySearchStrategy.pdf
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